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Administrative data

Description of key information

In an OECD and GLP study, the test item was not skin irritating.

In an OECD and GLP study, the test item was not eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: about 2.5 kg
- Housing: individual cages
- Diet: laboratory standard diet for rabbits (Altromin/Lage)
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL


Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not specified
- Type of wrap: adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7 days

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No indication of irritation after 1, 24, 48, 72 h or 7 days.
Other effects:
No indication to an incompatibility with the weight gains of untreated animals within the 7 days observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
Executive summary:

A skin irritation test was performed according to OECD 404 and GLP. In the study 5 rabbits were exposed to 0.5 mL of the undiluted test substance for 4 hours. After removal of the test substance the test site (2.5 x 2.5 cm) was evaluated after 1, 24, 48, 72 hours and 7 days. The mean erythema and edema score for 24/48/72h and 7 days were 0. Due to these results the test substance was found to be not skin irritating and without classification at 100 %.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1959
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: single cages
- Diet: standard laboratory diet for rabbits (Altromin, Lage)
- Water: e.g. ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Observation period (in vivo):
1, 2, 4, 8, 24, 48, 72 and 96 hours until day 7
Number of animals or in vitro replicates:
5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. After 24 h these irritaitions were fully reversible. In the iris and cornea no changes could be detected.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to the eye.
Executive summary:

The potential of the test substance to cause eye irritation was tested in five rabbits according to OEDC 404 and GLP. The animals were treated with 0.1 mL test substance and observed for 7 days. The mean score for cornea opacity and iris were 0 for 24/48/72 h. Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. The conjunctivae score was 0 for 24/48/72 h. All effects observed were reversible within 24 h. Due to these results the test substance was found to be not irritating for the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

A skin irritation test was performed according to OECD 404 and GLP. In the study 5 rabbits were exposed to 0.5 mL of the undiluted test substance for 4 hours. After removal of the test substance the test site (2.5 x 2.5 cm) was evaluated after 1, 24, 48, 72 hours and 7 days. The mean erythema and edema score for 24/48/72h and 7 days were 0. Due to these results the test substance was found to be not skin irritating and without classification at 100 %.

Eye irritation

The potential of the test substance to cause eye irritation was tested in five rabbits according to OEDC 404 and GLP. The animals were treated with 0.1 mL test substance and observed for 7 days. The mean score for cornea opacity and iris were 0 for 24/48/72 h. Till 8 hours post application slight to clear conjunctival irritations could be observed with slightly increased redness, chemosis and slightly increased secretion. The conjunctivae score was 0 for 24/48/72 h. All effects observed were reversible within 24 h. Due to these results the test substance was found to be not irritating for the eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.

Based on available data on eye irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.